Class II

Medical Device Recall: SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701

Angiodynamics, Inc. · June 18, 2024

Reason for Recall

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

595 boxes

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2454-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.